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Senior Manager (Level 1)

5+ years
Not Disclosed
10 Oct. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

We are Growing, Grow with Us!
Are you looking for a dynamic company where daily new challenges and opportunities await? Pharmalex is your career opportunity! As one of the leading service companies for the pharmaceutical industry globally, we specialize in all aspects of drug and medical device approval, market development, and effective product maintenance.

Position: Senior Manager (Level 1)

Locations: Mumbai/Noida

Your Role

In this position, you will collaborate in designing strategies for coordinated services with the VDC. You will provide a comprehensive range of regulatory affairs services for various clients across multiple product types and therapeutic areas. Your responsibilities will include:

  • Leading and supporting CMC activities, including project management, gap analysis, and CMC strategies.
  • Conducting quality control reviews of documentation, compendial cross-checking, and report formatting.
  • Performing critical technical reviews of documentation based on established expertise.
  • Offering consulting support for CMC activities.
  • Acting as the line manager for assigned staff.
  • Managing project coordination and resource allocation.

Your Profile

  • Education: Graduate/Post-graduate/Doctorate degree in life sciences, pharmacy, medical sciences, or equivalent.
  • Experience: 5-8 years of relevant experience in regulatory affairs or the biotech industry.
  • Skills:
    • Ability to work autonomously with a concentrated, high-quality approach.
    • Strong teamwork capabilities and a sense of responsibility.
    • Excellent command of English, both written and verbal, particularly in client-facing interactions.
    • Established experience in regulatory affairs activities, including Module 3 IND/IMPD authoring and review, MAA/BLA gap analysis, and regulatory strategy.
    • Familiarity with a wide range of biotech product types, including ATMPs, vaccines, recombinant proteins, and biosimilars.
  • Attributes: Well-organized, detail-oriented, and committed to delivering high standards while striving to exceed expectations.

How to Apply

If you're interested in joining our Pharmalex team and taking on this exciting challenge, we look forward to receiving your application. Please include your earliest possible starting date, any visa requirements, and salary expectations.

For further inquiries, feel free to reach out to us!

Agencies only by prior agreement for the specific job opportunity.